STAT+: FDA delays decision on Sarepta’s gene therapy for Duchenne muscular dystrophy
The FDA is delaying by one month a decision on the approval of a gene therapy for Duchenne muscular dystrophy, the treatment’s maker, Sarepta Therapeutics, said Wednesday.
The Food and Drug Administration is delaying by one month a decision on the approval of a gene therapy for Duchenne muscular dystrophy, the treatment’s maker, Sarepta Therapeutics, said Wednesday.
Sarepta said the FDA expects to complete the review of its gene therapy called SRP-9001 by June 22. A decision had been expected on or before May 29.
The company also said the agency “is working toward potentially granting an accelerated approval for SRP-9001” but only for 4-year-old and 5-year-old patients. The company had asked the agency to give the drug accelerated approval for all Duchenne patients who could still walk, which would have included most patients under the age of 10 and even some in their teens.
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